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Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00857285
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : July 23, 2009
Last Update Posted : July 23, 2009
Daiichi Sankyo Taiwan Ltd.
Information provided by:
Daiichi Sankyo, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Essential Hypertension
Interventions: Drug: olmesartan medoxomil
Drug: losartan potassium

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 181 subjects were screened at 3 study sites in Taiwan from May 2002 to April 2003, and 51 subjects had dropped as screen failure.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After a taper off period for 1 week, if necessary, and a placebo run-in period for 2 weeks, 130 subjects were randomized to olmesartan 20mg and losartan 50mg by 1:1 ratio.

Reporting Groups
Olmesartan Medoxomil olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Losartan Potassium losartan potassium oral tablets, once daily for up to 12 weeks

Participant Flow:   Overall Study
    Olmesartan Medoxomil   Losartan Potassium
STARTED   65   65 
COMPLETED   53   59 
Adverse Event                4                2 
Lack of Efficacy                0                2 
Protocol Violation                3                1 
Withdrawal by Subject                4                0 
Randomization criteria not met                1                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Olmesartan Medoxomil olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Losartan Potassium losartan potassium oral tablets, once daily for up to 12 weeks
Total Total of all reporting groups

Baseline Measures
   Olmesartan Medoxomil   Losartan Potassium   Total 
Overall Participants Analyzed 
[Units: Participants]
 65   65   130 
[Units: Years]
Mean (Standard Deviation)
 49.63  (10.69)   48.34  (9.17)   48.98  (9.94) 
[Units: Participants]
Female   33   23   56 
Male   32   42   74 
Race/Ethnicity, Customized 
[Units: Participants]
Taiwanese   65   65   130 
Region of Enrollment 
[Units: Participants]
Taiwan   65   65   130 

  Outcome Measures

1.  Primary:   Mean Change of Sitting dBP From Baseline to Week 12   [ Time Frame: Baseline to 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Senior Director, Regulatory Operations
Organization: Daiichi Sankyo, Inc.
phone: 732-590-5000
e-mail: hmkessler@dsus.com

Responsible Party: Ammy Chou, Director, Daiichi Sankyo Taiwan Ltd.
ClinicalTrials.gov Identifier: NCT00857285     History of Changes
Other Study ID Numbers: TSP-866/01
First Submitted: March 5, 2009
First Posted: March 6, 2009
Results First Submitted: May 28, 2009
Results First Posted: July 23, 2009
Last Update Posted: July 23, 2009